Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental… (NCT04816175) | Clinical Trial Compass
CompletedNot Applicable
Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay
United States4 participantsStarted 2019-04-30
Plain-language summary
This trial will consist of a clinical series of up to 50 children with Global Developmental Delay and concomitant microcephaly or hyperkinetic movements. All children will be assessed for psychomotor function using standardized assessments, goal specific assessments, with the potential addition of neuroimaging assessment, prior to and after receiving an intensive burst of neuromotor therapy. The interventional effects will be explored by comparing the pre and post interventional assessments and neuroimaging.
Who can participate
Age range
6 Months – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of Global Developmental Delay with Microcephaly or hyperkinetic movements.
Exclusion Criteria:
* Medical Instability
* Under 6 months of age over 15 years of age
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline on Motor Function Assessment
Timeframe: 5-12 weeks
Trial details
NCT IDNCT04816175
SponsorVirginia Polytechnic Institute and State University